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Obrixtamig + Chemotherapy for Carcinoid Tumor

Not yet recruiting at 162 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
Must be taking: Platinum, Etoposide
Must not be taking: DLL3-targeting, Anti-PD-1
Disqualifiers: Leptomeningeal disease, Merkel cell carcinoma, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).

Participants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.

During the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have advanced extrapulmonary neuroendocrine carcinoma with high tumor growth rate.
My tumor is mostly made up of neuroendocrine cancer cells (over 70%).
I am fully active or have only minor physical limitations.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obrixtamig and standard chemotherapy or standard chemotherapy alone

4 months
Regular visits, with overnight stays for the first 2 obrixtamig treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 38 months

Open-label extension

Participants in the treatment arm may continue obrixtamig alone for up to 3 years

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Etoposide
  • Obrixtamig

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Obrixtamig + carboplatin + etoposideExperimental Treatment4 Interventions
Group II: Carboplatin + etoposideActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

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